Senior Engineer Development Quality

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

The Opportunity

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Senior Engineer Development Quality assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

What You’ll Work On

• Lead on-time completion of Design Control Deliverables

• Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes, including active cross-functional root-cause analysis investigation & resolution activities

• Create and execute or direct validation protocols traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports

• Provide guidance and training to the site engineers for Software Validation, Data Integrity, Software Requirement Specification (SRS), Cybersecurity and also other support software systems.

• Lead CAPA investigations through effective root cause analysis and corrective action implementations

• Lead Risk Management activities from product Concept through Commercialization including cybersecurity risks

• Support manufacturing process development & qualification for new product commercialization and product changes

• Support/lead and ensure internal & external audit responses

• Support/lead and ensure on time product re-certifications

• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, product and nonproduct software requirements

• Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing).

• Complete Document Change Request Reviews in a timely and objective manner

• Develop and lead other team members.

• Perform other duties and responsibilities as assigned by management.

• Support/lead all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXP